A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma (ASCT)
|ClinicalTrials.gov Identifier: NCT01969942|
Recruitment Status : Withdrawn (No subjects meeting study inclusion were enrolled.)
First Posted : October 25, 2013
Last Update Posted : May 9, 2017
The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:
- The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
- The incidence of transplant related mortality at 100 days.
|Condition or disease||Intervention/treatment||Phase|
|Ewing Sarcoma||Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina Drug: Busulfan Drug: Melphalan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
|Biological: allogeneic stem cell transplantation Drug: Busulfan Drug: Melphalan|
Experimental: allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
|Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina|
- Development of Grade 3-4 GVHD [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969942
|United States, Kentucky|
|Pediatric Hematology/Oncology University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Kenneth Lucas, M.D.||University of Louisville|